Transcatheter Closure versus Medical Therapy of Patent Foramen Ovale and Presumed Paradoxical Thromboemboli

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Abstract
The optimal strategy to prevent recurrent presumed paradoxical emboli in patients with patent foramen ovale is unknown. To synthesize the current knowledge about and qualitatively assess the relative benefits of transcatheter closure versus medical therapy for patent foramen ovale. English-language and foreign-language journals listed in the MEDLINE database from January 1985 to July 2003 were systematically searched. Secondary sources were also used. Secondary prevention studies of transcatheter closure or medical therapy for patent foramen ovale were required to include at least 10 patients followed for more than 1 year and to report recurrent neurologic events. Data from published studies were manually extracted and summarized. Ten studies of transcatheter closure (1355 patients) and 6 studies of medical therapy (895 patients) for patent foramen ovale were included. Overall, the 1-year rate of recurrent neurologic thromboembolism with transcatheter intervention was 0% to 4.9%, and the incidence of major and minor complications was 1.5% and 7.9%, respectively. Medical management was associated with a 1-year recurrence rate of 3.8% to 12.0%. However, limitations resulting from uncontrolled data, nonstandardized definitions, vigilance of follow-up, and baseline imbalances preclude definitive conclusions about the superiority of a particular approach. General differences in study samples included older age, greater proportion of men, and higher prevalence of diabetes and smoking among medically treated patients. Patients undergoing treatment with a transcatheter device were more likely to have had multiple thromboembolic events at baseline. Transcatheter closure of patent foramen ovale may prevent a substantial proportion of cryptogenic strokes. Randomized clinical trials are needed.

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